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基于常规收集健康医疗数据的上市药品安全性评价研究设计和分析技术专家共识 被引量:1
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作者 王雯 刘梅 +12 位作者 何俏 田春华 宋海波 王涛 谭婧 任燕 高培 彭晓霞 温泽淮 舒啸尘 邹康 沈传勇 孙鑫 《中国药物警戒》 2022年第1期7-12,共6页
作为真实世界数据的重要组成,常规收集的健康医疗数据(RCD)已广泛应用到上市后药品安全性评价。但如何生成高质量的RCD证据支持上市后药品安全性监管决策,在研究设计和分析上还存在挑战。本专家共识通过阐明RCD的定义、应用,并针对研究... 作为真实世界数据的重要组成,常规收集的健康医疗数据(RCD)已广泛应用到上市后药品安全性评价。但如何生成高质量的RCD证据支持上市后药品安全性监管决策,在研究设计和分析上还存在挑战。本专家共识通过阐明RCD的定义、应用,并针对研究设计、数据分析提出基于RCD的上市后药品安全性评价基本要求及注意事项,以期促进我国高质量的研究证据的生产及应用。 展开更多
关键词 真实世界数据 药品安全性评价 常规收集健康医疗数据
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糖尿病患者住院期间降糖药调整的相关因素:基于美国130家医院数据的Logistic回归分析
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作者 施亚男 施羽 +1 位作者 樊春笋 姚红玉 《海南医学》 CAS 2020年第20期2594-2597,共4页
目的评估糖尿患者群因任何疾病住院后降糖药治疗方案调整的相关因素。方法自在线资源库(https://archive.ics.uci.edu/ml/datasets.php)获取美国1999—2008年间130家医院因任何疾病住院的糖尿患者群数据集,剔除未行糖化血红蛋白检测者,... 目的评估糖尿患者群因任何疾病住院后降糖药治疗方案调整的相关因素。方法自在线资源库(https://archive.ics.uci.edu/ml/datasets.php)获取美国1999—2008年间130家医院因任何疾病住院的糖尿患者群数据集,剔除未行糖化血红蛋白检测者,以降糖药治疗方案是否改变作为研究结局,采用单因素和多因素Logistic回归计算患者临床特征与研究结局之间的关联及强度。结果共纳入具备糖化血红蛋白检测结果的研究对象14339例,其中8067例(56.26%)发生研究结局。在八项离散数值临床特征中,单因素和多因素Logistic回归分析结果显示均为危险因素的共有三项,各指标及调整后的OR(95%CI)如下:入院化验数1.002(1.000~1.005),入院药物使用数1.078(1.071~1.085),急诊就诊数1.160(1.089~1.235);P值均<0.05。在14项二分类临床特征中,单因素和多因素Logistic回归分析结果显示均为危险因素的有10项,各指标及调整后的OR(95%CI)如下:男性1.121(1.046~1.202);年龄<60岁,1.134(1.054~1.220);非急诊入院,1.153(1.073~1.239);主诊断非心血管疾病,1.153(1.068~1.244);入院诊断数>6,1.275(1.177~1.380);入院化验数>49,1.127(1.048~1.212);入院药物使用数>14,2.245(2.075~2.428);急诊就诊数≥1,1.471(1.296~1.671),住院天数>7,1.224(1.110~1.351);糖化血红蛋白>7%,2.118(1.965~2.283)。P值均<0.05。结论糖尿患者群因任何疾病住院期间降糖药调整与多项临床特征或指标密切相关,其中最重要的是糖化血红蛋白,应作为糖尿患者群因任何疾病入院前的必查项目。 展开更多
关键词 糖尿病 住院 降糖药调整 LOGISTIC回归 糖化血红蛋白 常规收集健康数据 横断面研究
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Challenges using electronic nursing routine data for outcome analyses:A mixed methods study
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作者 Renate Nantschev Elske Ammenwerth 《International Journal of Nursing Sciences》 CSCD 2022年第1期92-99,I0006,共9页
Objectives To explore the challenges of secondary use of routinely collected data for analyzing nursing-sensitive outcomes in Austrian acute care hospitals.Method A convergent parallel mixed methods design was perform... Objectives To explore the challenges of secondary use of routinely collected data for analyzing nursing-sensitive outcomes in Austrian acute care hospitals.Method A convergent parallel mixed methods design was performed.We conducted a quantitative representative survey with nursing managers from 32 Austrian general acute care hospitals and 11 qualitative semi-structured interviews with nursing quality management experts.Both results were first analyzed independently and afterward merged in the discussion.Results On average,76%of nursing documentation is already electronically supported in the surveyed Austrian hospitals.However,existing nursing data is seldom used for secondary purposes such as nursing-sensitive outcome analyses.This is due to four major reasons:First,hospitals often do not have a data strategy for the secondary use of routine data.Second,hospitals partly lack the use of standardized and uniform nursing terminologies,especially for nursing evaluation.Third,routine nursing data is often not documented correctly and completely.Fourth,data on nursing-sensitive outcomes is usually collected in specific documentation forms not integrated into routine documentation.Conclusion The awareness of the possibilities for secondary use of nursing data for nursing-sensitive outcome analyses in Austrian hospitals is still in its infancy.Therefore,nursing staff and nursing management must be trained to understand how to collect and process nursing data for nursing-sensitive outcome analyses.Further studies would be interesting in order to determine the factors that influence the decision-making processes for the secondary use of nursing data for outcome analyses. 展开更多
关键词 Austria Health care quality indicators Nursing care plan Nursing informatics Routinely collected health data Secondary use Standardized nursing terminology
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